How to Prepare For and Host an FDA Inspection and Respond to 483’s
Duration: 60 Minutes
Faculty: Edwin Waldbusser Course ID: 1027 Level: Advance
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one. You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and how to respond to 483s and warning letters. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.
Why should you Attend:
FDA will inspect you! Are you ready? FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483’s than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility. 483’s and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection.
In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures.
Can you afford not to be prepared?
Areas Covered in the Session:
- Personnel preparation
- Facility requirements to support inspection
- Procedure to follow during audit-what to do/ what not to do
- Behavior during inspection-what not to sign
- Internal/ mock audits
- Why the FDA issues such citations
- What is a 483 and what does it look like
- What is a Warning letter and what does it look like
- What is the difference between a 483 and a Warning Letter
- What they mean for your company
- How to respond to 483s and Warning Letters to avoid escalation by the FDA
- How to prevent future issues during an inspection and avoid future issuances of 483s and Warning Letters
Who Will Benefit:
- Regulatory VPs
- Quality VPs
- IT VPs
- Regulatory Affairs Professionals
- Quality Managers
- Quality Engineers
- Small business Owners
- GxP Consultants
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.